Sr Research Scientist Large Molecule

Work Schedule

Environmental Conditions

Job Description

This is a fully onsite role based at our GMP Laboratory in Greenfield IN . We welcome applicants from all locations within the U.S.

Must be legally authorized to work in the United States without sponsorship.

Must be able to pass a comprehensive background check which includes a drug screening.

Discover Impactful Work:
As a Sr Research Scientist you will oversee complex analytical development and/or specialty technologies projects to create new analyticalmethods enhance existing methods and transfer client-provided methods using multiple instrumentationtechniques (HPLC GC UPLC ICP-MS LC/MS GC/MS etc.) and multiple detection techniques (UV FLCAD ELSD IC etc.). Provide technical and regulatory consulting to internal groups and clients abouttheir programs. Provide technical guidance and mentorship to senior staff members in performing laboratory activities. Routinely act as the technical project leader for multiple projects interacts withclients to provide technical project updates reviews and evaluates data writes reports and protocols.

What Youll Do:
Independently plans the best scientific approach to develop analytical methods
and/or other specialty technologies studies that meet client requirements.
Acts as on-site Subject Matter Expert (SME) for instrumentation / technique /
technology.
Evaluates available technical options to obtain desired quality of analytical
results economics ease of introduction into a production environment and
robustness in analytical applications.
Demonstrates viability of in-house developed methods and methods transferred
from clients by designing appropriate validation experiments or other appropriate
aspects of specialty methodology or technology.
Ability to lead client discussions regarding project definitions technical
information exchanges and discussions of project status. Provides
recommendations to clients on technical and regulatory issues.
Reviews protocols project status reports final study reports and other projectrelated technical documents.
Assists business development group in technical sales and marketing and in
preparation of technical marketing materials and presents posters and makes
podium presentations at conferences.
Leads in preparation and implementation of SOPs and quality systems as well as
developing innovative technology and in evaluating and implementing new
capabilities.
Reviews interprets and analyzes data for technical quality and compliance to
protocols methods SOPs client criteria and Good Manufacturing Practices
(GMP) or Good Laboratory Practices (GLP). Performs self and peer review of the
data for accuracy and compliance with reporting requirements prior to
submission to QA and issuance to customers

Education and Experience Requirements:
Bachelors degree (Life Sciences degree) or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 10 years).

In some cases an equivalency consisting of a combination of appropriate education training and/or directly related experience will be considered sufficient for an individual to meet the requirements of the role.

Knowledge Skills Abilities:

Solid understanding and knowledge of general chemistry and separation science

Demonstrated knowledge of multiple applicable techniques such as: HPLC ELISA GC MS Dissolution Testing Inhalation Testing Biopharmaceutical Testing Karl Fischer UV-Vis FT-IR TOC
Effective written and oral communication skills as well as presentation skills
Knowledge and application of industry best practices not yet represented by global regulatory
requirements
Full theoretical and hands-on understanding and knowledge of general chemistry and separation
science
Demonstrated ability of integrating changing regulatory or industry standards and comprehension of
technical limitations
Full understanding of laboratory requirements SOPs ICH guidelines USP requirements and FDA
guidance
Ability to independently review and understand project proposals/plans
Proven ability in technical writing skills
Ability to work in a collaborative work environment with a team
Proven problem solving and troubleshooting abilities
Ability to independently optimize analytical methods
Time management and project management skills

Working Conditions and Environment:

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Able to communicate receive and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

• Able to work upright and stationary and/or standing for typical working hours.

• Able to lift and move objects up to 25 pounds.

• Able to work in non-traditional work environments.

• Able to use and learn standard office equipment and technology with proficiency.

• May have exposure to potentially hazardous elements including infectious agents typically found in healthcare or laboratory environments.

• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

Why Join Us
When you join Thermo Fisher Scientific you become part of a global team that values passion innovation and a commitment to scientific excellence. Youll work in an environment where collaboration and development are part of the everyday experienceand where your contributions truly make a difference.

Apply today to help us deliver tomorrows breakthroughs.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other legally protected status.

Accessibility/Disability Access

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